The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Danniflex Model 500tm Cpm.
| Device ID | K904735 |
| 510k Number | K904735 |
| Device Name: | DANNIFLEX MODEL 500TM CPM |
| Classification | Exerciser, Powered |
| Applicant | BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Contact | W Schlerf |
| Correspondent | W Schlerf BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-17 |
| Decision Date | 1991-01-30 |